Is Phesgo approved by the FDA?

Yes, Phesgo (a combination of hyaluronidase, pertuzumab, and trastuzumab) is FDA approved. The U.S. Food and Drug Administration (FDA) approved Phesgo on June 29, 2020, for the treatment of HER2-positive breast cancer.

What is Phesgo?

Phesgo is a cancer medicine used to treat early-stage breast cancer and HER2-positive breast cancer that is advanced or has metastasized (spread to other parts of the body). Phesgo is specifically used for breast cancer that tests positive for the HER2 protein, which can accelerate the growth of cancer cells.

How is Phesgo Administered?

Phesgo is administered as an injection under the skin of the thigh by a healthcare provider. The treatment is usually given once every three weeks for up to one year. Patients are monitored closely for 15 to 30 minutes after the injection to ensure they do not experience a serious reaction.

Key Warnings and Precautions

Heart and Lung Issues:

• Phesgo can cause life-threatening heart or lung problems. Symptoms like trouble breathing, swelling, rapid weight gain, fast or pounding heartbeats, or light-headedness should be reported to a doctor immediately.

Pregnancy and Birth Control:

• Phesgo can cause birth defects or death to an unborn baby. Effective birth control must be used during treatment and for at least seven months after the last dose. A negative pregnancy test is required before starting treatment.

Pre-existing Conditions:

• Patients with a history of congestive heart failure, heart attacks, heart rhythm disorders, uncontrolled high blood pressure, weak immune systems caused by chemotherapy, or those who have had chemotherapy treatment with doxorubicin should inform their doctor before starting Phesgo.

Side Effects

Serious Side Effects:

• New or worsening cough or shortness of breath
• Fast or pounding heartbeats
• Severe headache, blurred vision
• Swelling in the face or lower legs
• Rapid weight gain
• Low white or red blood cell counts

Common Side Effects:

• Nausea, diarrhea
• Anemia
• Feeling weak or tired
• Hair loss
• Rash
• Numbness, tingling, or burning pain in hands or feet

Monitoring During Treatment

Due to the potential long-lasting effects on the heart, heart function needs to be checked every six months for at least two years after the last dose of Phesgo. It is also crucial to inform any doctor treating you with chemotherapy about your Phesgo treatment for at least seven months after the last dose.

Conclusion

Phesgo was approved by the FDA on June 29, 2020, as an effective treatment for HER2-positive breast cancer. This combination therapy of hyaluronidase, pertuzumab, and trastuzumab provides a targeted approach to managing this specific type of breast cancer. However, due to its potential severe side effects and specific usage requirements, it is vital for patients to undergo thorough monitoring and adhere to their doctor's instructions throughout the treatment.

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